Rapid exchange balloon dilation catheter having reinforced multi-lumen distal portion

ABSTRACT

A rapid exchange balloon dilation catheter includes a catheter shaft with a proximal tubular member defining a proximal inflation/deflation lumen for conveying fluids therethrough with a distal portion of the bore of proximal tubular member filled with a fluid-impervious barrier, a distal body extending from the fluid-impervious barrier to the distal end of the shaft, a plurality of distal tubular members defining distal inflation/deflation lumens in fluid communication with the proximal inflation/deflation lumen and extending through the fluid-impervious barrier and the distal body to the distal end of the shaft distal portion, a guidewire tubular member having a bore extending from a side aperture formed in the distal body through the distal body alongside the distal tubular members in a multi-lumen arrangement, and a plurality of stiffening members extending from within the fluid-impervious barrier into the distal body to a point within the shaft distal portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/480,949, filed Jun. 9, 2009, now U.S. Pat. No. 7,985,236 and entitledRAPID EXCHANGE BALLOON DILATION CATHETER HAVING REINFORCED MULTI-LUMENDISTAL PORTION, which is a continuation of U.S. patent application Ser.No. 11/174,676, filed Jul. 5, 2005, now U.S. Pat. No. 7,544,201, issuedJun. 9, 2009, and entitled RAPID EXCHANGE BALLOON DILATION CATHETERHAVING REINFORCED MULTI-LUMEN DISTAL PORTION, the specifications ofwhich are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The current invention relates generally to angioplasty apparatus, andmore specifically to balloon dilation catheters. In particular, itrelates to a rapid exchange-type balloon dilation catheter having adistal end that comprises multiple lumens and additional structuralreinforcements.

BACKGROUND

As treatment using balloon dilation catheters, for example, PercutaneousTransluminal Angioplasty Catheters (i.e., “PTACs”), has progressed intonarrower and more remote vessels within the body, this has necessitatedthe use of catheters having correspondingly smaller shaft diameters andlonger shaft lengths. However, this migration towards catheters withsmaller diameter, longer shafts has produced several new problems of itsown. First, catheter inflation/deflation time performance (i.e., thetime required for inflation and deflation of the balloon) has tended toincrease in the longer, smaller diameter catheters as frictionalresistance to movement of the inflation fluid through the ballooninflation/deflation lumens of the catheter becomes significant. Second,accessing increasingly smaller body lumens requires that the distalportion of the catheter shaft have sufficient lateral (i.e.,side-to-side) flexibility to follow the guidewire as it twists and turnsthrough the smaller, more arduous pathways in the body. If the distalend of the catheter is not flexible enough, it may pull the guidewireout of position in the target lumen rather than follow it. Theflexibility of the distal portion of the catheter is often referred toas the “trackability” of the catheter.

In a rapid-exchange type catheter, the guidewire does not run throughthe entire length of the catheter shaft, but rather runs parallel to theshaft for the majority of it's length, then enters the shaft through aside aperture and runs through only the distal portion of the shaft andthe dilation balloon. The side aperture region has a reduced crosssection that tends to be a weak point in the structure, andreinforcement in this area is often required. However, the reinforcementnecessary to support the side aperture area tends to make the distalportion of the shaft so stiff that it has insufficient trackability.

A need therefore exists, for a rapid exchange balloon dilation catheter(and shaft therefor) with improved trackability in the distal portion.Preferably, the trackability will increase toward the distal end of theshaft.

SUMMARY

The present invention disclosed and claimed herein comprises, in oneaspect thereof, a rapid exchange balloon dilation catheter adapted to beutilized with a guidewire. The catheter comprises an elongated cathetershaft having a shaft proximal portion, a shaft distal portion, and ashaft transitional portion disposed therebetween. Each of the proximal,distal and transitional shaft portions has a proximal end and a distalend. A balloon having a proximal end, a distal end and an interior isattached at its proximal end to the distal end of the shaft distalportion. The catheter shaft includes a proximal tubular member having abore and extending from the proximal end of the shaft proximal portioninto the shaft transitional portion. The proximal portion of the boredefines a proximal inflation/deflation lumen for conveying fluidstherethrough, and the distal portion of the bore is filled with afluid-impervious barrier. A distal body extends from thefluid-impervious barrier to the distal end of the shaft distal portion.A plurality of distal tubular members are provided, each having a boreand extending from the proximal inflation/deflation lumen through thefluid-impervious barrier and the distal body to the distal end of theshaft distal portion. The bores of the distal tubular members definedistal inflation/deflation lumens for conveying fluids therethrough, thedistal inflation/deflation lumens being in fluid communication with theproximal inflation/deflation lumen at their proximal ends and with theinterior of the balloon at their distal ends. A guidewire tubular memberis provided, having a bore and originating from a side aperture formedin the distal body, extending through the distal body alongside thedistal tubular members in a multi-lumen arrangement, then through theinterior of the balloon to the distal end of the balloon. The bore ofthe guidewire tubular member defines a guidewire lumen for conveying aguidewire through the shaft distal portion and the balloon. A pluralityof stiffening members are provided, each stiffening member extendingfrom within the fluid-impervious barrier and into the distal body to arespective point within the shaft distal portion.

The present invention disclosed and claimed herein comprises, in anotheraspect thereof a shaft for a rapid exchange balloon dilation catheter tobe utilized with a guidewire. The shaft comprises a shaft proximalportion, a shaft distal portion, and a shaft transitional portiondisposed therebetween. Each of the proximal, distal and transitionalshaft portions has a proximal end and a distal end. A proximal tubularmember has a bore and extending from the proximal end of the shaftproximal portion into the shaft transitional portion, the proximalportion of the bore defining a proximal inflation/deflation lumen forconveying fluids therethrough and the distal portion of the bore beingfilled with a fluid-impervious barrier. A distal body extends from thefluid-impervious barrier to the distal end of the shaft distal portion.A plurality of distal tubular members are provided, each distal tubularmember having a bore and extending from the proximal inflation/deflationlumen through the fluid-impervious barrier and the distal body to thedistal end of the shaft distal portion. The bores of the distal tubularmembers define distal inflation/deflation lumens for conveying fluidstherethrough, the distal inflation/deflation lumens being in fluidcommunication with the proximal inflation/deflation lumen at theirproximal ends and having a fluid passage at their distal ends forconveying fluids out of the distal end of the shaft distal portion. Aguidewire tubular member is provided having a bore and originating froma side aperture formed in the distal body, extending through the distalbody alongside the distal tubular members in a multi-lumen arrangement,then extending beyond the distal end of the distal body. The bore of theguidewire tubular member defines a guidewire lumen for conveying aguidewire through the shaft distal portion. A plurality of stiffeningmembers is provided, each stiffening member extending from within thefluid-impervious barrier and into the distal body to a respective pointwithin the shaft distal portion.

The present invention disclosed and claimed herein comprises, in afurther aspect thereof, a shaft for a balloon dilation catheter to beutilized with a guidewire. The shaft comprises a shaft proximal portionincluding a proximal tubular member having a bore defining a proximalinflation/deflation lumen. A shaft transitional portion is connected toa distal end of the shaft proximal portion and includes a plurality ofdistal tubular members and a plurality of stiffening members. Theproximal ends of the distal tubular members and the stiffening membersare attached to an inner distal surface of the proximal tubular memberby a fluid-impervious barrier. Each distal tubular member has a boredefining a distal inflation/deflation lumen, and a proximal end of eachdistal inflation/deflation lumen is in fluid communication with a distalend of the proximal inflation/deflation lumen. A shaft distal portion isconnected to a distal end of the shaft transitional portion and includesa distal body and a guidewire tubular member. The distal body encasesthe guidewire tubular member and portions of the distal tubing membersand the stiffening members, which run alongside one another through thedistal body in a multi-lumen arrangement. The guidewire tubular memberhas a bore and extends from a side aperture formed in the distal body tobeyond the end of the distal body. The bore of the guidewire tubularmember defines a guidewire lumen for conveying a guidewire therethrough.The distal tubing members extend to the distal end of the distal body,the distal ends of the distal inflation/deflation lumens forming fluidoutlets. The stiffening members extend to points disposed between theside aperture and the distal end of the distal body.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding, reference is now made to thefollowing description taken in conjunction with the accompanyingDrawings in which:

FIG. 1 is an elevation view with partial cross-section of arapid-exchange balloon dilation catheter in accordance with a firstembodiment and the associated guidewire;

FIG. 2 is an enlarged cross-sectional elevation view of portions of thecatheter shaft of FIG. 1;

FIG. 3 is a plan view with partial cross-section of the portions of thecatheter shaft of FIG. 2;

FIG. 4 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 4-4 of FIG. 1;

FIG. 5 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 5-5 of FIGS. 2 and 3;

FIG. 6 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 6-6 of FIGS. 2 and 3;

FIG. 7 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 7-7 of FIGS. 2 and 3;

FIG. 8 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 8-8 of FIGS. 1, 2 and 3;

FIG. 9 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 9-9 of FIGS. 1, 2 and 3;

FIG. 10 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 10-10 of FIGS. 1, 2 and 3;

FIG. 11 is a cross-sectional end view of the catheter shaft andassociated guidewire taken along the line 11-11 of FIGS. 1, 2 and 3;

FIG. 12 is a cross-sectional end view through the balloon portion of thecatheter taken along the line 12-12 of FIG. 1;

FIG. 13 a is a simplified diagram of a catheter distal body withembedded stiffening members in accordance with another embodiment;

FIG. 13 b is a graph of stiffness versus distal position for the distalbody with embedded stiffening members of FIG. 13 a;

FIG. 14 a is a simplified diagram of a catheter distal body withembedded stiffening members in accordance with yet another embodiment;

FIG. 14 b is a graph of stiffness versus distal position for the distalbody with embedded stiffening members of FIG. 14 a;

FIG. 15 a is a simplified diagram of a catheter distal body withembedded tapered stiffening members in accordance with a furtherembodiment;

FIG. 15 b is a graph of stiffness versus distal position for the distalbody with embedded stiffening members of FIG. 15 a; and

FIGS. 16 a and 16 b are a flow chart showing a method for manufacturinga hybrid catheter shaft in accordance with another embodiment.

DETAILED DESCRIPTION

The current invention is described below in greater detail withreference to certain preferred embodiments illustrated in theaccompanying drawings.

Referring now to FIG. 1, there is illustrated a balloon dilationcatheter in accordance with one embodiment of the current invention.While this design may be used to make catheters of any diameter, it isparticularly suitable for small diameter catheters, e.g., those having adiameter of 5 French or smaller. The catheter 20 includes a shaft 22having a proximal end 24 that may be affixed to an inflation fitting 26and a distal end 28 that may be affixed to a dilation balloon 30. Asexplained in further detail below, a plurality of tubular memberscomprising the catheter 20 define a plurality of internal passageways,known as lumens. One such tubular member, the guidewire tubular member,extends longitudinally through a portion of the catheter shaft 22. Theguidewire tubular member has a bore defining a guidewire lumen thatallows a conventional guidewire 32 to be threaded through thecorresponding portion of the catheter shaft 22. However, unlikeconventional guidewire catheters, wherein the guidewire tubular memberextends through the entire shaft 22 from the proximal end 24 to thedistal ends 28, the current invention has a so-called “rapid exchange”design wherein the guidewire lumen extends through only the distalportion of the shaft 22, and then exits from the shaft through a sideaperture 33 disposed somewhere between the distal end 28 and proximalend 24 of the shaft. A guidewire manipulator or “torquer” 34 may besecured to the guidewire 32 for rotating the guidewire from the proximalend of the catheter. Other tubular members within the catheter shaft 22define inflation/deflation lumens that convey contrast liquid or othernon-compressible inflation fluids through the shaft to and from theballoon, thereby allowing the balloon to be selectively inflated anddeflated. The access fitting 26 may be of conventional design, having afluid port 36 in fluid communication with the shaft'sinflation/deflation lumens.

The dilation balloon 30 may be of conventional construction and istypically formed of a relatively non-distensible plastic or polymermaterial. The envelope of the balloon may be plain, or it may bereinforced with longitudinal, circumferential and/or helical filamentsor other reinforcing members. For purposes of illustration, the balloon30 is shown in its inflated configuration in FIG. 1, however, it will beappreciated that the deflated balloon can typically be folded in such amanner as to have an outside diameter that is approximately the same asthat of the catheter shaft 22. It will further be appreciated that thelength and diameter of the balloon 30 may vary significantly from thatillustrated in FIG. 1 without departing from the scope of the currentinvention.

The balloon 30 may be attached to the distal end 28 of the cathetershaft 22 using various techniques and configurations known in the art.In the embodiment shown in FIG. 1, an epoxy adhesive is used to connectthe proximal end 37 of the balloon directly to the exterior surfaces ofthe guidewire tubular member 38 and the inflation/deflation lumens wherethey extend from the end of the catheter shaft. This allows the proximalend 37 of the balloon to butt up against the distal end 28 of the shaftas shown. It will be understood that the lumens are typically protected(e.g., with removable mandrels) during the joining procedure to ensurethat adhesive does not block the lumen openings. The distal end 31 ofthe balloon is connected with a fluid tight seal to the outside (i.e.,radial) surface of the guidewire tubular member 38, which extends beyondthe distal end of the catheter shaft and passes through the interior ofthe balloon 30 as shown. The distal end 40 of the guidewire 32 can beseen exiting from the distal end of the guidewire tubular member 38,which typically marks the distal end of the catheter. Theinflation/deflation lumens of the catheter, as described in greaterdetail below, empty from the distal ends 28 of the catheter shaft 22into the balloon interior 42, thereby allowing inflation and deflationof the balloon 30 by selectively introducing and withdrawing fluidthrough the fluid port 36 of the access fitting 26.

In order to achieve both high inflation/deflation time performance andhigh distal flexibility (and hence trackability) the catheter 20 of thecurrent invention has a shaft 22 including a shaft proximal portion 44having a single lumen configuration disposed toward the proximal end 24of the shaft, a shaft distal portion 46 having a multi-lumenconfiguration disposed toward the distal end 28 of the shaft, and ashaft transitional portion 48 disposed therebetween. Typically, theshaft proximal portion 44 constitutes a majority of the catheter shaft'soverall length, while the shaft distal portion 46 constitutes a minorityof the catheter shaft's overall length.

The shaft proximal portion 44 has a proximal end at the proximal end 24of the shaft and a distal end abutting the proximal end of the shafttransitional portion 48. The shaft proximal portion 44 includes a singleinflation/deflation lumen, but does not include an internal guidewirelumen. The shaft distal portion 46 has a proximal end abutting thedistal end of the shaft transitional portion 48 and a distal end at thedistal end 28 of the shaft. The shaft distal portion 46 includes aninternal guidewire lumen and a plurality of inflation/deflation lumensrunning parallel to, but separate from, the guidewire lumen. The shafttransitional portion 48 is disposed between the shaft proximal portion44 and the shaft distal portion 46 as just described. The internalconfiguration of the catheter shaft 22 transitions from the single lumenconfiguration of the shaft proximal portion 44 to the multi-lumenconfiguration of the shaft distal portion 46. The side aperture 33 forinsertion of the guidewire 32 into the distal portion of the shaft isdisposed within this transitional portion.

As described in further detail below, the distal portion 46 of the shaftexhibits progressive increasing flexibility between side aperture 33 andthe distal end 28. In other words, the flexibility of the distal portion46 of the shaft becomes progressively greater (i.e., it is easier tobend) as the distance from the side aperture 33 increases. Thisprogressive distal flexibility allows the distal portion 46 of thecatheter shaft 22 to be relatively flexible near the balloon 30 formaximum trackability and relatively stiff near the side aperture 33 toprevent excessive bending at the point of reduced cross-section. Theprogressive distal flexibility may be exhibited as a continuousreduction in the stiffness of the shaft, or as a series of step-wisereductions in the stiffness of the shaft. At a minimum, there will be atleast one change in the stiffness of the distal portion of the shaft,and preferably two or more changes in stiffness of the distal portion ofthe shaft between the side aperture 33 and the distal end 28.

Referring now to FIGS. 2 and 3, there are illustrated, respectively, across-sectional side view and a partial cross-sectional elevation viewof the catheter shaft 22 centered on the transitional portion 48. Itwill be appreciated that for purposes of illustration, selected portionsof the shaft 22 having a constant cross-section have been omitted (asindicated by the broken end lines), thus the actual length of the shaftand/or portions thereof, may be greater than that shown in the figures.

Referring now to FIG. 4, there is illustrated a lateral cross-section ofthe proximal portion 44 of the shaft, i.e., the single lumen portion. Itwill be appreciated that, for purposes of illustration, the wallthicknesses of the various tubular members may not be shown to scale inFIGS. 1-12, and the spacings between the various tubular members andaround the guidewire may be exaggerated for clarity. The shaft proximalportion 44 includes a proximal tubular member 50 having a bore 52 thatserves as the proximal inflation/deflation lumen. As previouslydescribed, the proximal inflation/deflation lumen 52 is in fluidcommunication with the fluid port 36 of the access fitting 26, allowingthe catheter shaft to transport inflation fluid for inflating theballoon 30. Accordingly, the proximal tubular member 50 must be strongenough to withstand the balloon's maximum inflation pressure withoutbursting. As in other rapid exchange catheters, the guidewire 32 is notconveyed through the proximal portion 44 of the catheter shaft, butrather is disposed externally as shown.

The proximal tubular member 50 of the shaft proximal portion 44 may beformed of suitable materials such as plastic, elastomers, metal or metalalloy. For some catheters, the proximal tubular member 50 may be formedof Nylon-11 or of polyether block amide (PEBA) thermoplastic elastomer,such as that sold under the trademark Pebax®. In some cases, theNylon-11 or PEBA elastomer may be loaded with approximately 20% bismuthby weight to provide partial radiopacity. For other catheters,especially for small diameter catheters, e.g., those having an outsidediameter of about 5 French or smaller, it is preferred to use higherstrength materials for the proximal tubular member 50 in order to keepthe wall thickness as low as possible, and also to provide adequatetorsional stiffness to the overall shaft 22. Thus, in preferredembodiments, the proximal tubular member 50 is made of polyamideplastic, which is significantly stiffer than either Nylon-11 or PEBA.

The proximal tubular member 50 may be sheathed in a jacket 56 made of adifferent material. Typically, the jacket 56 is not used to provideadditional structural strength, but rather to change certaincharacteristics of the shaft proximal portion 44 (i.e., as compared tothe characteristics of the proximal tubular member 50 alone). Forexample, ordinary polyamide plastic is relatively radio-transparent, andnot easily loaded with radiopacifiers. Thus, where tubular member 50 ismade of polyamide plastic, the jacket 56 may be made of the radiopaquematerial to make the proximal portion 44 of the catheter shaft morevisible by radiography. In other examples, the proximal jacket 56 may bemade of a material that provides a smooth exterior surface thatminimizes the tendency for blood cells to accumulate thereupon and/or ofa hydrophilic material that exhibits lubricity when it comes intocontact with blood. The jacket 56 may be extruded or co-extruded aroundthe proximal tubular member 50 during its manufacture, or it may bebonded to the proximal tubular member by thermal-compression molding orsimilar processes at a later time. In a preferred embodiment, theproximal portion jacket 56 is formed of a polyether block amide (PEBA)thermal plastic elastomer such as that sold under the trademark Pebax®.PEBA elastomer such as Pebax® brand PEBA may be readily loaded withradiopacifiers, e.g., bismuth, and are available in plasticizer andadditive-free medical grade. Thus, in another preferred embodiment, theproximal tubular member 50 is made of a polyamide plastic and theproximal portion jacket 56 is made of Pebax® brand grade 7233 PEBAloaded with approximately 20% (by weight) bismuth.

Referring again to FIGS. 2 and 3, and now also to FIGS. 5-11, furtherdetails of the configuration of the shaft 22 are shown. As previouslydescribed, the proximal portion 44 of the shaft has a single lumenconfiguration including a proximal tubular member 50, the bore of whichdefines a proximal inflation/deflation lumen 52 and may further includea jacket 56 sheathing the exterior surface of the proximal tubularmember. The proximal tubular member 50, and jacket 56 (if present)extend past the distal end of the shaft proximal portion 44 and formpart of the shaft transitional portion 48. However, in the shafttransitional portion, the bore 52 of the proximal tubular member 50 isfilled with a fluid-impervious barrier 58, effectively terminating theproximal inflation/deflation lumen 52. Extending through the fluidbarrier 58 are a plurality of distal tubular members 60, each of whichhas a bore 62 defining a distal inflation/deflation lumen that is influid communication with the proximal inflation/deflation lumen 52. Alsoextending at least into, if not through, the fluid barrier 58 is atleast one stiffening member 64.

The shaft transitional portion 48 further includes a portion of a distalbody 66 disposed distally adjacent to the fluid barrier 58. The distalbody 66 may extend somewhat into the distal end of the proximal tubularmember 50, however, this is not required. The distal body 66 extends (inthe distal direction) through the rest of the shaft transitional portion48 and into the shaft distal portion 46. Embedded within the distal body66 is a guidewire tubular member 68 having a bore 70 defining aguidewire lumen for slidingly receiving the guidewire 32. The proximalend of the guidewire tubular member 68 is typically disposed a shortdistance from the fluid barrier 58, and may be cut at a slant orotherwise shaped to facilitate entry of the guidewire 32 into theguidewire lumen 70. The distal body 66 is cut back or molded to have areduced cross-section at the proximal end of the guidewire tubularmember 68, thereby forming the side aperture 33 that allows passage ofthe guidewire to and from the guidewire lumen 70.

Extending through the distal body 66 below the reduced cross-sectionarea of the side aperture 33 are the distal tubular members 60 andstiffening members 64. The distal tubular members 60 allow inflationfluid to continue traveling from the proximal end 24 of the cathetershaft 22 toward the distal end 28. The stiffening members 64 providestructural support to the distal body 66 in the region of reducedcross-section at the side aperture 33, preventing the shaft from beingso weak that it buckles or otherwise fails during normal handling oruse.

The distal portion 46 of the shaft is disposed distally adjacent to theshaft transitional portion 48, and extends to the distal end 28, whereit is adapted for connection to the proximal end 37 of the balloon 30.The proximal end of the shaft distal portion 46 may be considered to bethe first cross-sectional plane where the full guidewire tubular member68, distal tubular member 60 and stiffening member 64 are all present,however, this is somewhat arbitrary and has no particular effect on thescope of the invention. It is significant, however, that the shaftdistal portion has progressive distal flexibility, i.e., the distalportion of the shaft becomes more flexible (i.e., less stiff) as it getscloser to the distal ends 28.

In the embodiment shown in FIGS. 2 and 3, the progressive distalflexibility of the shaft distal portion 46 results from the staggeredtermination of multiple stiffening members 64. As best seen in FIG. 3,the two stiffening members 64 are terminated at different points betweenthe side aperture 33 and the distal end 28. Since the guidewire tubularmember 68 and distal tubular members 60 extend continuously through theshaft distal portion 46, the shaft will get more flexible (i.e., lessstiff) at the point each stiffening member 68 is discontinued. Forexample, at the plane of the cross-section of FIG. 9, two stiffeningmembers 64 are present, and the shaft will have relatively highstiffness/low flexibility. Moving distally to the plane of thecross-section of FIG. 10, one of the stiffening members has beendiscontinued, thus only one stiffening member is present. Accordingly,the shaft at this point will be less stiff/more flexible than it was atthe previous cross-section. Moving distally still further to the planeof the cross-section of FIG. 11, both stiffening members 64 have nowbeen discontinued, and no stiffening members are present. Accordingly,the shaft at this point will be even less stiff/more flexible than itwas at the previous cross-section. This is only one example ofprogressive distal flexibility, and it will be appreciated that manyother configurations may be used. For example, by changing the number ofthe stiffness members, and/or the spacing between their terminations,the progressive flexibility of the distal portion of the shaft may betailored as desired, e.g., the flexibility may increase linearly withdistal position in one example and have a nonlinear relation to distalposition in another example.

Referring now to FIGS. 13 a, 13 b, 14 a, 14 b, 15 a and 15 b, there areillustrated examples of alternative configurations for providingprogressive distal flexibility in additional embodiments. FIG. 13 ashows a simplified representation of the distal body 66 a between anintermediate point 72 and the distal end of the shaft 28. Embeddedwithin the distal body 66 a are four stiffening members 64 of equalconstant cross-section, but having different lengths varying accordingto a linear relationship. If the stiffening members 64 are aligned atthe proximal end, this arrangement will produce a distal body 66 ahaving a step-wise decreasing stiffness (S) that has a generally linearrelationship with distal position (P), as shown in FIG. 13 b. It will beappreciated that flexibility is inversely proportional to stiffness.Thus, the distal body 66 a will exhibit distally progressive flexibilityhaving a generally linear nature.

FIG. 14 a shows a simplified representation of a distal body 66 b havingembedded there within four stiffening members 64 of equal cross-sectionarea but having the different lengths varying according to a nonlinearrelationship. If the stiffening members 64 are aligned at the proximalend 72, this arrangement will produce a distal body 66 b having astep-wise decreasing stiffness (S) that has a generally nonlinearrelationship with distal position (P), as shown in FIG. 14 b.

FIG. 15 a shows a simplified representation of a distal body 66 csimilar to those described above. Embedded within the distal body 66 care two stiffening members 64′, however, these strengthening members donot have a constant cross-section, but rather have a taperedconfiguration such as might be obtained by heating and stretchingplastic rods or by molding or machining tapered rods. If the stiffeningmembers 64′ are aligned at the proximal end 72 the arrangement willproduce a distal body 66 c having a continuously decreasing stiffnesscharacterized by two linear portions having different slopes as shown inFIG. 15 b. In this manner, the flexibility of the distal portion of thecatheter shaft 22 may be customized according to particular proceduresor to a particular user's preference.

The distal tubular members 60 may be formed of suitable materials suchas plastic, elastomers, metal or metal alloy. For small diametercatheters, it is preferred to use high strength materials for the distaltubular members in order to keep their wall thicknesses as low aspossible, and also to provide adequate torsional stiffness to the shaftdistal portion 46. In preferred embodiments, the distal tubular members60 are made of polyamide plastic. The guidewire tubular member 68 mayalso be formed of suitable material such as plastic, elastomers, metalor metal alloy. Among the plastics suitable for use are Nylon, includingNylon-11, and polyamide plastic. For small diameter catheters, e.g.,those having an outside diameter of about 5 French or smaller, it ispreferred to use higher strength materials such as polyamide in order tokeep the wall thickness as low as possible and thereby maximize thecross-sectional area available for the guidewire lumen 70 and the distalinflation/deflation lumens 62. Thus, in preferred embodiments, both theguidewire tubular member 38 and the distal tubular members 60 will bemade of polyamide plastic.

The stiffening, members 64 may be made of suitable materials such asplastic, elastomers, metal or metal alloys. Although the stiffeningmembers 64 may be tubular, this is not required since the stiffeningmembers do not incorporate the lumen. Thus, the stiffening members 64may be shaped as tubes, rods, plates, channels or other structuralshapes. The stiffening members may be of constant cross-section, such asextrusions, or they may be tapered (see FIG. 15 a) or have othervariable cross-sections. In a preferred embodiment, the stiffeningmembers 64 are made of polyetheretherketone (PEEK) thermoplastic. PEEKhas a natural tensile strength of approximately 13,000-14,000 PSI, andmay be filled with glass fibers or carbon fibers to yield higher tensilestrengths, e.g., approximately 22,500 PSI for 30% glass file andapproximately 30.000 PSI for 30% carbon fiber fill.

As previously described, the fluid barrier 58 serves to block theproximal inflation/deflation lumen 52, thereby forcing the inflationfluid to flow through the distal inflation/deflation lumen 62 to reachthe balloon 30. However, the fluid barrier 58 also serves to anchor thetransitional portion 48 and distal portion 46 of the shaft to theproximal portion 44 by bonding the exterior surfaces of the distaltubing members 60 and stiffening members 64 to the interior surfaces ofthe proximal tubing member 50. Various conventional bonding agents suchas glues, epoxies and the like may be used with the fluid barrier 58,provided the material has sufficient fluid resistance, adhesive strengthand mechanical strength to resist the maximum balloon inflation pressureand the mechanical forces exerted on the catheter during handling anduse. In a preferred embodiment, a two part medical grade epoxy is usedfor the fluid barrier 58.

In a preferred embodiment, the distal body 66 is formed of a plastic orelastomer material that can be molded around the tubular members 60 and68 and the stiffening member 64 by thermal-compression molding, i.e.,using pressure and heat. In one embodiment, the distal body 66 is formedof a polyether block amide (PEBA) thermal plastic elastomer, such asPebax® brand PEBA. PEBA thermal plastics may be molded using pressureand heat. Since flexibility is desirable for the shaft distal portion46, using a relatively soft PEBA formulation for the distal body 66appears to have advantages. If radiopacity is required, the distal body66 may be made of a radiopaque material or filled with a radiopaquematerial such as bismuth. In a preferred embodiment, the distal body 66is made of a Pebax® brand grade 4033 PEBA. In a more preferredembodiment, the distal body is made of PEBA filled with approximately20% (by weight) bismuth.

As best seen in FIG. 2, in some embodiments, the proximal end 74 of thedistal body 66 may be tapered to fit into the extreme distal end of theproximal tubular member 50 (e.g., to assist in aligning the two portionsduring assembly). Since it is preferable that the outside diameter ofthe catheter shaft 22 be as smooth as possible, a filler band 76 may beadded to the shaft after connection of the shaft transitional portion 48to the shaft proximal portion 44. The filler band 76 may be made of asuitable material that is compatible with the adjacent proximal jacket56 and distal body 66. The material of the filler band 76 may be thesame as that of the jacket 56 for the distal body 66, or it may be adifferent material altogether. Preferably, the material of the fillerband 76 will be a plastic or elastomer material that can be moldedaround the perimeter of the assembled catheter shaft 22 using pressureand heat (e.g., thermal compression molding). In one preferredembodiment, the filler band 76 is formed of a polyether block amide(PEBA) thermal plastic elastomer such as Pebax® brand PEBA.

Referring now to FIG. 5, there is illustrated a cross-section of thecatheter shaft 22 taken near the distal end of the shaft proximalportion 44. The configuration of the shaft is essentially the same asthat shown in FIG. 4, including the proximal tubular member 50 and thejacket 56. The proximal inflation/deflation lumen 52 defined by the boreof the proximal tubular member 50 is present at the point of thecross-section, however, the barrier 58 is physical nearby in the distaldirection. The proximal ends of the distal tubular member 60 andstiffening members 64 are also visible extending from the nearby end ofthe barrier 58. The distal inflation/deflation lumens 62 are seenopening into the proximal inflation/deflation lumen 52 such that thereis fluid communication between them. The guidewire 32 remains outsidethe catheter shaft at this point.

Referring now to FIG. 6, there is illustrated a cross-section of thecatheter shaft 22 taken near the proximal end of the transitionalportion 48. The proximal tubular member 50 and proximal jacket 56 arestill present, however, the proximal inflation/deflation lumen is nolonger present, its place having been taken by the barrier 58. Thedistal tubular member 60 and stiffening members 64 extend through thebarrier 58. It will be appreciated that the barrier 58 bonds the distaltubular member 60 and stiffening members 64 to the interior of theproximal tubular member 50, thereby securing the transitional and distalportions of the shaft to the proximal portion. The guidewire 32 remainsoutside the catheter shaft at this point.

Referring now to FIG. 7, there is illustrated a cross-section of thecatheter shaft 22 taken through an intermediate part of the transitionalportion 48. At this point, the distal body 66 has replaced the proximaltubular member 50, the jacket 56 and the barrier 58. The distal tubularmembers 60 and the stiffening members 64 are embedded in the distal body66, serving to anchor the distal body to the proximal portions of thecatheter shaft. The distal inflation/deflation lumens 62 allow inflationfluid to be conveyed through the shaft toward the balloon 30. Theguidewire 32 remains outside the catheter shaft at this point.

Referring now to FIG. 8, there is illustrated a cross-section of thecatheter shaft 22 taken near the distal end of the transitional portion48. At this point, the distal body 66 has a reduced cross-section due tothe presence of the side aperture 33. Nearby in the distal direction,the proximal end of the guidewire tubular member 68 can be seen enteringthe distal body 66 through the distal wall 78 of the side aperture. Theguidewire 32 can also be seen entering the guidewire lumen 70 defined bythe bore of the guidewire tubular member 68. The distal tubular members60 and the stiffening members 64 are embedded in the remaining portionof the distal body 66. The distal inflation/deflation lumen 62 allowsinflation fluid to be conveyed through the shaft toward the balloon 30.The stiffening members 64 provide reinforcement of the catheter shaft 22at the point of reduced cross-section necessitated by the presence ofthe side aperture 33. If the stiffening members 64 were not present,then either the shaft would be subject to excessive bending and possiblefailure at the side aperture 33, or alternatively, the distal tubularmembers 60 would have to be much stiffer (e.g., thicker walls and/orstronger material), which would not be conducive to providing thenecessary flexibility that is needed at the distal end of the cathetershaft near the balloon 30.

Referring now to FIGS. 9-11, there are illustrated successivecross-sections of the catheter shaft 22 taken through the shaft distalportion 46 moving from near the proximal end toward the distal end.Referring now specifically to FIG. 9, at this point the distal body 66has returned to a full-diameter cross-section. Embedded within thedistal body 66 are the guidewire tubular members 68 and the distaltubular members 60 with their respective lumens 70 and 62. The guidewire32 can pass through the guidewire lumen 70 and inflation fluid can passthrough the distal inflation/deflation lumens 62. Both stiffeningmembers 64 are also embedded in the distal body, providing high relativestiffness to the shaft at this point. Referring next specifically toFIG. 10, at this point the shaft has substantially the sameconfiguration as in FIG. 9, except that one of the stiffening members 64is not present, having terminated in the intervening portion of theshaft (see FIG. 3). This results in the catheter shaft having lessthickness, i.e., greater flexibility, than it had at the point of theprevious cross-section. Referring next specifically to FIG. 11, at thispoint the shaft has substantially the same configuration as in FIG. 10,except that there are no stiffening members 64 present, the lastremaining stiffening member having terminated in the intervening portionof the shaft (again, see FIG. 3). This of course results in the cathetershaft having even less stiffness, i.e., even greater flexibility, thanit had at the point of the cross-section of FIG. 10. Thus, the staggeredtermination of the stiffening member 64 provides the distal portion 46of the shaft with progressively increasing flexibility toward the distalends 28.

Referring now to FIG. 12, there is illustrated a representative lateralcross-section of the catheter 20 taken through the inflated dilationballoon 30. The cross-section illustrated in FIG. 12 is taken facingtowards the distal end 28 of the catheter shaft 22 and the proximal end37 of the balloon. The guidewire tubular member 68 and its lumen 70 passentirely through the balloon 30, however, the distal tubular members 60terminate near the distal end 28 of the catheter, and their respectivedistal inflation/deflation lumens 62 are in fluid communication with theballoon interior 42. Thus, the combination of the proximal and distalinflation/deflation lumens 52 and 62 provide a continuous fluid channelthrough the catheter shaft 22 between the access fitting 26 on theproximal end 24 and the balloon interior 42 on the distal end 28. Thisallows the balloon 30 to be selectively inflated or deflated via thefluid port 36 of the access fitting 26.

Referring now to FIGS. 16 a and 16 b, there is illustrated a method formanufacturing a catheter shaft and a balloon dilation catheter inaccordance with another embodiment. The method of manufacture 1600begins with providing tubes for the proximal tubular member, guidewiretubular member and distal tubular member as represented by blocks 1602,1604 and 1606, respectively. The various tubular members may be made ofplastics or other materials as previously described. In preferredembodiments, one or all of the proximal tubular member, guidewiretubular member and distal tubular members are made from polyimideplastic. Next, a mandrel made of steel or other noncompressible materialis inserted into the bore of each of the tubes as shown in blocks 1608,1610 and 1612, respectively. The outer diameter of each mandrel isselected to slip closely within the bore of its respective tubularmember, thereby providing support for the walls of the tubular memberduring subsequent processing steps, and ensuring that unwanted materialsdo not enter the bores of the tubular members during subsequentprocessing steps.

In addition, stiffening members are provided as indicated in block 1607.The SM may be made of plastic or other materials as previouslydescribed. The SM may be rods, tubes, plates or other shapes aspreviously described, which may have constant or variable crosssections. In preferred embodiments, the SM are made from PEEK plasticrods having a constant cross section.

As the method 1600 continues, the tubular members and SM may requireadditional processing. For convenience, the following description willfirst describe the additional processing of the proximal tubular memberto form a proximal subassembly, then the processing of the remainingtubular members and SM. However, it will be appreciated that the orderof processing these members may be changed without departing from thescope of the invention. As shown in block 1614, the proximal tubularmember is next loosely sheathed with a suitable jacket raw material,e.g., PEBA thermoplastic elastomer. Such jacket material is oftensupplied in the form of an extruded tube that may be slipped over theproximal tubular member, however, other forms of jacket raw material maybe used. Next, as shown in block 1616, the jacket material is bonded tothe exterior of the proximal tubular member using thermal compressionmolding or other known bonding techniques. In thermal compressionmolding, a combination of heat and pressure causes the molding materialto “flow” and adhere to the exterior of the subject member. In apreferred embodiment, the thermal compression molding is accomplished byplacing a length of heat-shrink tubing over the previously assembledjacket raw material, proximal tubing member and mandrel, then heatingthis assembly in an oven. The heat from the oven serves to soften thejacket material so that it may flow, while at the same time the heatcauses the heat-shrink tubing to shrink, thereby compressing thesoftened jacket material tightly against the exterior or the proximaltubular member. The mandrel inside the bore of the proximal tubularmember prevents the collapse of the tubing walls even though they aresubjected to considerable compression forces during the molding process.The compression molding provided by the heat-shrink tubing when heatedis very uniform, thereby avoiding the formation of seam lines or anyother surface irregularities on the surface of the jacket that mightresult from other molding techniques. After the jacket has been bondedto the exterior of the proximal tubular member, the heat-shrink tubingmay be removed from the assembly, as indicated in block 1618. Of course,in embodiments which do not include the exterior jacket, the operationshown in blocks 1614, 1616 and 1618 may be omitted. After jacketing, themandrel may be removed from at least the distal end of the proximaltubular member as shown in block 1620. The proximal tubular member andjacket, if present, may next be cut to their final lengths or otherwisefurther processed, completing preparation of a proximal subassembly asindicated in block 1622.

The method 1600 for constructing the catheter shaft now continues withfurther details of the construction of a distal subassembly. First, theguidewire tubular member and distal tubular members, with theirrespective mandrels installed as shown in blocks 1610 and 1612, and theSM as shown in block 1607, are prepared for encasement in the distalbody of the shaft, as shown in block 1624. This preparation may includecutting the members to predetermined lengths and arranging them inpredetermined configuration for assembly. Typically, the members will bearranged so that the distal end of the guidewire tubular member extendspast the distal tubular members and SM in the distal direction, theproximal ends of the distal tubular members and SM extend past theguidewire tubular member in the proximal direction, and the SM terminateat staggered points along the guidewire tubular member. Next, as shownin block 1626, portions of the guidewire tubular member, distal tubularmembers and SM are loosely sheathed with the raw material to be used forthe distal body. It is important to note that various portions of theguidewire tubular member, distal tubular members and SM are not sheathedwith this material as they will remain unencased by the distal body. Inparticular, the proximal ends of the distal tubing members and SM willbe left unsheathed for connection to the proximal subassembly, and thedistal end of the guidewire tubular member will be left unsheathed forlater connection to the balloon. In a preferred embodiment, the rawmaterial for the distal body is provided in the form of an extrudedplastic tube that can be slipped over portions of the guidewire tubularmember, distal tubular members and SM, which are then positionedrelative to one another and relative to the raw distal body tube aspreviously described. In a preferred embodiment, the sheathing materialis a PEBA thermoplastic elastomer.

Next, as shown in block 1628, the distal body raw material is moldedaround the sheathed portions of the guidewire tubular member, distaltubular members and SM using thermal compression molding to form thedistal body. As previously described, this thermal compression moldingmay be accomplished by slipping a length of heat-shrink tubing over thepreviously assembled guidewire tubular member, distal tubular members,SM and sheathing material, and then heating the entire assembly in anoven. The heat will soften the distal body raw material allowing it toflow between and around the various members under the pressure generatedby the contracting heat-shrink tubing. The guidewire tubing member anddistal tubing member are protected from collapse during the thermalcompression molding by the presence of the mandrels within theirrespective bores. As previously described, the heat shrink tubingprovides exceptionally smooth surface finish on the final molded distalbody. After the thermal compression molding is complete, thethermal-compression fixturing (e.g., heat-shrink tubing) may be removedas shown in block 1630. Finally, any required trimming of the exposedends of the members, tapering of the proximal end of the distal body andother post-molding procedures (block 1631) may be performed to completethe distal subassembly as indicated in block 1632. It will beappreciated that construction of the proximal subassemblies and thedistal subassemblies are essentially independent of one another suchthat it makes no difference which subassembly is completed first in themethod 1600.

Once a proximal subassembly and a distal subassembly are available,final assembly may proceed as indicated in block 1634. In finalassembly, an adhesive or bonding resin, e.g., a two-part medical gradeepoxy, is applied to the distal subassembly around the exposed distaltubular members and SM in the area immediately adjacent to the proximalend of the distal body. Adhesive may also be applied to the interiordistal end of the proximal subassembly. Next, as shown in block 1636,the proximal ends of the distal tubing members and SM (of the distalsubassembly) are inserted into the bore of the proximal tubular member(of the proximal subassembly) until the adhesive-coated region adjacentto the distal body abuts against the distal end of the proximalsubassembly. This adhesive will form the fluid-tight barrier filling thedistal part of the proximal inflation/deflation lumen of the shaft,while at the same time providing the structural connection between theproximal subassembly and the distal subassembly. Since the mandrelsremain in place within the distal tubular members during the bondingprocess, no adhesives are able to enter the bores of these tubes andcause an undesired obstruction.

In a preferred embodiment, the proximal end of the distal subassemblymay be slightly tapered prior to final assembly to facilitate thecentering of the distal subassembly in the open end of the proximalsubassembly. In such embodiments, the taper may result in the creationof an undesirable seam, gap or depression on the surface of the shaft atthe joint between the proximal subassembly and the distal subassembly.As shown in block 1638, a band of filler material may be added into thegap or depression at the joint between the distal subassembly and theproximal subassembly to smooth the exterior of the shaft. This fillermay be bonded (block 1640) through the use of thermal compressionmolding by first slipping a tube of raw filler material over the unevenregion, then slipping a length of heat-shrink tubing over the fillermaterial and surrounding shaft, and then heating it in an oven. Aspreviously explained, the raw filler material will be softened by theheating, and the heat-shrink tubing will then contract to providepressure molding that bonds the filler material to the shaft surface andeliminates any unevenness in the shaft surface formed during finalassembly. This method of assembly will result in the exterior surface ofthe catheter shaft being very smooth around the junction area.

After all thermal compression molding is completed, the mandrels may beremoved from the guidewire tubular member, the distal tubular membersand proximal tubular member as indicated in block 1642. Next, any finaltrimming of the guidewire tubular member and distal tubular members todesired lengths may be performed as shown in block 1644. Further, theside aperture may be cut open to expose the guidewire lumen. Thiscompletes construction of the catheter shaft as shown in block 1646. Thecatheter shafts manufactured using this method may subsequently beattached to dilation balloons and access fittings (block 1648) tomanufacture complete catheter assemblies (block 1650), or alternatively,they may be sold as components for use by others in constructing theirown catheters. It will be appreciated that while the assembly method1600 described above is a preferred method of constructing the cathetershafts and catheters previously described in connection with FIGS. 1-12,variations of this method and other methods may also be used forproducing the catheter shafts without departing from the scope of theinvention.

While the invention has been shown or described in a variety of itsforms, it should be apparent to those skilled in the art that it is notlimited to these embodiments, but is susceptible to various changeswithout departing from the scope of the invention.

What is claimed is:
 1. A rapid exchange balloon dilation catheter, thecatheter comprising: a catheter shaft; and a balloon having a proximalend, a distal end and an interior, the proximal end of the balloon beingattached to the distal end of the catheter shaft; the catheter shaftfurther including: a fluid impervious barrier; a plurality of distaltubular members associated with the fluid-impervious barrier andextending to the interior of the balloon; a guidewire tubular memberhaving a bore extending from a side aperture and through the interior ofthe balloon to the distal end of the balloon; and a plurality ofstiffening members for stiffening the catheter shaft, wherein thestiffening members include members of different lengths.
 2. The catheterof claim 1, wherein the catheter shaft further includes a proximalsection proximal to the fluid impervious barrier, said proximal sectionincluding a single proximal lumen.
 3. The catheter of claim 2, whereinthe plurality of distal tubular members are in communication with theproximal lumen for transferring inflation fluid to and from the balloon.4. The catheter of claim 2, wherein the fluid impervious barrierconnects the proximal lumen to the distal tubular members.
 5. Thecatheter of claim 1, wherein the stiffening members are associated withthe portion of the catheter shaft including the side aperture.
 6. Thecatheter of claim 5, wherein the stiffening members extend to variouspoints of the catheter shaft distal to the side aperture such that thecatheter shaft becomes less rigid toward a distal portion of thecatheter shaft.
 7. A rapid exchange balloon dilation catheter, thecatheter comprising: a catheter shaft having a proximal end and a distalend; and a balloon having a proximal end, a distal end, and an interior,the proximal end of the balloon being attached to the distal end of thecatheter shaft; the catheter shaft further including: a fluid imperviousbarrier including at least one tubular member adapted for allowing theinflation fluid to reach the interior of the balloon; a guidewire tubehaving a bore originating from a side aperture and extending through theinterior of the balloon to the distal end of the balloon; and aplurality of stiffening members extending through at least a portion ofthe catheter shaft.
 8. The catheter of claim 7, wherein the stiffeningmembers are associated with a portion of the catheter shaft includingthe side aperture.
 9. The catheter of claim 7, wherein the stiffeningmembers include members of different lengths.
 10. The catheter of claim7, wherein the shaft becomes more flexible from the side aperture to thedistal end of the shaft.
 11. The catheter of claim 10, wherein theflexibility of the shaft increases linearly toward the distal end of theshaft.
 12. The catheter of claim 10, wherein the flexibility of theshaft increases in a nonlinear fashion toward the distal end of theshaft.
 13. The catheter of claim 7, wherein at least one of thestiffening members has a cross section that varies along its length. 14.The catheter of claim 7, further including a single lumen in theproximal end of the catheter shaft and multiple lumens in the distal endof the catheter shaft.
 15. A catheter shaft for use in a rapid exchangeballoon dilation catheter with a guidewire, comprising: a tubular memberincluding a side aperture for receiving the guidewire; a fluidimpervious barrier positioned in the tubular member for selectivelyallowing inflation fluid to reach the balloon; a single proximalinflation lumen and a plurality of distal inflation lumen; a guidewiretube adapted for receiving the guidewire; and a plurality of stiffeningmembers extending through the catheter shaft.
 16. The shaft of claim 15,wherein the fluid impervious barrier diverts inflation fluid from theproximal inflation lumen to the distal inflation lumen.
 17. The shaft ofclaim 16, wherein the shaft increases in flexibility from the sideaperture to a distal end of the shaft.
 18. The shaft of claim 15,wherein the fluid impervious barrier is bonded to the stiffeningmembers.
 19. A rapid exchange balloon dilation catheter, the cathetercomprising: a catheter shaft; and a balloon having a proximal end, adistal end and an interior, the proximal end of the balloon beingattached to the distal end of the catheter shaft; the catheter shaftfurther including: a fluid impervious barrier; a plurality of distaltubular members associated with the fluid-impervious barrier andextending to the interior of the balloon; a guidewire tubular memberhaving a bore extending from a side aperture and through the interior ofthe balloon to the distal end of the balloon; and a plurality ofstiffening members for stiffening the catheter shaft, wherein thestiffening members extend to various points of the catheter shaft distalto the side aperture such that the catheter shaft becomes less rigidtoward a distal portion of the catheter shaft.
 20. The catheter of claim19, wherein the catheter shaft further includes a proximal sectionproximal to the fluid impervious barrier, said proximal sectionincluding a single proximal lumen.
 21. The catheter of claim 20, whereinthe plurality of distal tubular members are in communication with theproximal lumen for transferring inflation fluid to and from the balloon.22. The catheter of claim 20, wherein the fluid impervious barrierconnects the proximal lumen to the distal tubular members.
 23. Thecatheter of claim 19, wherein the stiffening members are associated withthe portion of the catheter shaft including the side aperture.